FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Venous Return Cannulae
K Number: K250937
·
Decision Mar 11, 2026
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
3
Review Days
348
Basic Information
- Device Name
- Venous Return Cannulae
- K Number
- K250937
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- LivaNova USA, Inc.
- Date Received
- March 28, 2025
- Decision Date
- March 11, 2026
- Product Code
- DWF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWF), ordered by most recent decision date.
Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae
FDA 510(k)
FDA Class 2
·Cardiovascular
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
FDA 510(k)
FDA Class 2
·Cardiovascular
Retrograde Coronary Sinus Perfusion Cannulae
FDA 510(k)
FDA Class 2
·Cardiovascular
Dual Stage Venous Cannulae
FDA 510(k)
FDA Class 2
·Cardiovascular
Clearview Intracoronary Shunts
FDA 510(k)
FDA Class 2
·Cardiovascular
AngioVac Cannula
FDA 510(k)
FDA Class 2
·Cardiovascular